UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017563 |
|---|---|
| Receipt number | R000020341 |
| Scientific Title | Intensity-modulated radiation therapy for total body irradiation in hematopoietic stem cell transplantation: Phase II study |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2021/11/17 09:07:47 |
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Basic information
Public title
Intensity-modulated radiation therapy for total body irradiation in hematopoietic stem cell transplantation: Phase II study
Acronym
IMRT-TBI study
Scientific Title
Intensity-modulated radiation therapy for total body irradiation in hematopoietic stem cell transplantation: Phase II study
Scientific Title:Acronym
IMRT-TBI study
Region
| Japan |
Condition
Condition
hematopoietic malignancy
Classification by specialty
| Hematology and clinical oncology | Pediatrics | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess safety and efficacy of total body irradiation by intensity-modulated radiation therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Frequency of grade 3 or worse adverse events, based on CTCAE ver. 4.0, from 3 months to 1 year after total body irradiation.
Key secondary outcomes
Reccurence-free survial, overall survival, graft survival rate, time to graft survival, and frequency of grade 3 or worse adverse events in full observation period.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In our institution, total body irradiation are performed as preparative regimen for hematopoietic stem cell transplantation by intensity-modulated radiation therapy.
Prescribed dose is 12 Gy in 6 fractions in 3 days. Dose to lung is reduced under 10 Gy.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Undergoing hematopoietic stem cell transplantation by myeloablative preparation.
Performance status is from 0 to 2.
With informed consent. If the patient is underage, we obtain informed consent from parent or legal representation.
Key exclusion criteria
With serious complication.
With simultaneous double cancer or heterochronic double cancer in last 5 years.
With previous history of radiation.
Not being able to remain at rest during treatment.
With technical problem for intensity-modulated radiation therapy.
Being in pregnancy.
Judging inadequate by any medical, psychological or other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideomi |
| Middle name | |
| Last name | YAMASHITA |
Organization
The University of Tokyo Hospital
Division name
The department of Radiology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-5800-8667
yamachan07291973@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | TAKENAKA |
Organization
The University of Tokyo Hospital
Division name
The department of Radiology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-5800-8667
Homepage URL
rtakenaka-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-5800-5411
IRBjimu-tokyo@umin.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学医学部附属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
http://www.u-tokyo-rad.jp/data/IMRT-TBIprotocol.pdf
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 14 | Day |
Last modified on
| 2021 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020341
